PeriodontitisPeriRenNCT01094639
Periodontal Infection and Systemic Inflammation in Renal Patients
A study testing Scaling root planing and Supragingival Prophylaxis in people with Periodontitis and Chronic Kidney Disease, run by UConn Health at 1 site in United States.
Trial summary
The purpose of this study is to examine the role of gum disease in affecting the long term prognosis of renal patients. This disease if untreated causes inflammatory response throughout the body. If the subject has gum disease, he/she will be randomly assigned to one of the two treatment groups. Read more about this study
- Who is it for?
- Ages 21 to 85 years
- Conditions the study is for
- Periodontitis, Chronic Kidney Disease
- What is being tested?
- Scaling root planing and Supragingival Prophylaxis
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2009to Aug 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 21 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- dental subjects with periodontitis,
- at least 10 teeth
- no periodontal (gum) treatment for the last year,
- no antibiotic for the last 4 months,
- no vascular access infection.
Who cannot join
- smokers
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Connecticut Health Center
Farmington, Connecticut, 06030-1710
About this study
The purpose of this study is to examine the role of gum disease in affecting the long term prognosis of renal patients. This disease if untreated causes inflammatory response throughout the body. If the subject has gum disease, he/she will be randomly assigned to one of the two treatment groups. The study investigates what happens to inflammatory markers in blood and saliva after you are treated for gum disease.
Read the detailed description
The main goal of this project was to explore the contribution of chronic periodontitis to systemic inflammation in Chronic Kidney Disease (CKD). To achieve this goal, the project had two specific objectives:
- a) To compare the prevalence of periodontal infection between CKD and non-CKD populations and b) to explore the association between the presence of periodontal infection and the uremic status of CKD patients.
- a) To assess the levels of systemic inflammatory markers, IL-6 and CRP in the presence or absence of periodontal infection in CKD and b) to compare the serum IL-6 and CRP levels in response to periodontal intervention.
- Conditions
- Periodontitis, Chronic Kidney Disease
- Being tested
- Scaling root planing, Supragingival Prophylaxis
- Medical subject headings
- Periodontitis, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Scaling root planingProcedure or surgery
Deep gum cleaning with local anesthesia
Supragingival ProphylaxisProcedure or surgery
Plaque removal
| Study group | Role | What they receive |
|---|---|---|
| Supragingival prophylaxis | Placebo comparator | Plaque removal Receives: Procedure: Supragingival Prophylaxis |
| Scaling root planing | Active comparator | SRP+oral hygiene Receives: Procedure: Scaling root planing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels
IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.
Measured: 2 months
Secondary outcomes (1)
Changes in periodontal (gum) clinical presentation and status
For the secondary outcome, periodontal variables such as bleeding on probing, probing depth (the depth of the gum sulcus around the tooth), and bacterial plaque score will be evaluated to assess the effectiveness of the intervention and the compliance of the patients
Measured: 2 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2010 (estimated)
- Study startAug 2009
- Primary completionJul 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (8)Papers the sponsor has linked to this study.
- Other trials for PeriodontitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- UConn Health
- Sponsor type
- University, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Responsible party
- Principal investigator, Efthimia Ioannidou, UConn Health
- Investigators
- Efthimia Ioannidou, DDS, MDS, Principal investigator, UConn Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01094639
- Sponsor's protocol ID
- 10-092-2
- Other IDs
- K23DE018689
- Acronym
- PeriRen
- Status last verified
- Oct 2016
- First submitted
- 23 Mar 2010
- Last updated
- 25 Oct 2016
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Publications
Ioannidou E, Malekzadeh T, Dongari-Bagtzoglou A. Effect of periodontal treatment on serum C-reactive protein levels: a systematic review and meta-analysis. J Periodontol. 2006 Oct;77(10):1635-42. doi: 10.1902/jop.2006.050443.
PubMed 17032104Ioannidou E, Shaqman M, Burleson J, Dongari-Bagtzoglou A. Periodontitis case definition affects the association with renal function in kidney transplant recipients. Oral Dis. 2010 Oct;16(7):636-42. doi: 10.1111/j.1601-0825.2010.01665.x.
PubMed 20412451Ioannidou E, Swede H, Dongari-Bagtzoglou A. Periodontitis predicts elevated C-reactive protein levels in chronic kidney disease. J Dent Res. 2011 Dec;90(12):1411-5. doi: 10.1177/0022034511423394. Epub 2011 Sep 22.
PubMed 21940520Hong BY, Furtado Araujo MV, Strausbaugh LD, Terzi E, Ioannidou E, Diaz PI. Microbiome profiles in periodontitis in relation to host and disease characteristics. PLoS One. 2015 May 18;10(5):e0127077. doi: 10.1371/journal.pone.0127077. eCollection 2015.
PubMed 25984952Ioannidou E, Swede H. Disparities in periodontitis prevalence among chronic kidney disease patients. J Dent Res. 2011 Jun;90(6):730-4. doi: 10.1177/0022034511402209. Epub 2011 Mar 21.
PubMed 21422478Ioannidou E, Hall Y, Swede H, Himmelfarb J. Periodontitis associated with chronic kidney disease among Mexican Americans. J Public Health Dent. 2013 Spring;73(2):112-9. doi: 10.1111/j.1752-7325.2012.00350.x. Epub 2012 Jul 6.
PubMed 22775287Araujo MV, Hong BY, Fava PL, Khan S, Burleson JA, Fares G, Samson W, Strausbaugh LD, Diaz PI, Ioannidou E. End stage renal disease as a modifier of the periodontal microbiome. BMC Nephrol. 2015 Jun 9;16:80. doi: 10.1186/s12882-015-0081-x.
PubMed 26055269Ioannidou E, Swede H, Fares G, Himmelfarb J. Tooth loss strongly associates with malnutrition in chronic kidney disease. J Periodontol. 2014 Jul;85(7):899-907. doi: 10.1902/jop.2013.130347. Epub 2013 Nov 11.
PubMed 24215204
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Periodontal Infection and Systemic Inflammation in Renal Patients
- ClinicalTrials.gov ID
- NCT01094639
- Acronym / sponsor ID
- PeriRen / 10-092-2
- Conditions
- Periodontitis, Chronic Kidney Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- UConn HealthUniversity, hospital or other
- Collaborators
- National Institute of Dental and Craniofacial Research (NIDCR)
- Study start
- Aug 2009
- Primary completion
- Jul 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to examine the role of gum disease in affecting the long term prognosis of renal patients. This disease if untreated causes inflammatory response throughout the body. If the subject has gum disease, he/she will be randomly assigned to one of the two treatment groups. The study investigates what happens to inflammatory markers in blood and saliva after you are treated for gum disease.
Detailed description
The main goal of this project was to explore the contribution of chronic periodontitis to systemic inflammation in Chronic Kidney Disease (CKD). To achieve this goal, the project had two specific objectives:
- a) To compare the prevalence of periodontal infection between CKD and non-CKD populations and b) to explore the association between the presence of periodontal infection and the uremic status of CKD patients.
- a) To assess the levels of systemic inflammatory markers, IL-6 and CRP in the presence or absence of periodontal infection in CKD and b) to compare the serum IL-6 and CRP levels in response to periodontal intervention.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Supragingival prophylaxis | Placebo comparator | Procedure: Supragingival ProphylaxisPlaque removal |
| Scaling root planing | Active comparator | Procedure: Scaling root planingSRP+oral hygiene |
Who may qualify
- Ages
- 21 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- dental subjects with periodontitis,
- at least 10 teeth
- no periodontal (gum) treatment for the last year,
- no antibiotic for the last 4 months,
- no vascular access infection.
Key exclusion criteria (1 listed)
- smokers
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Scaling root planingDeep gum cleaning with local anesthesia | Procedure or surgery | Scaling root planing |
| Supragingival ProphylaxisPlaque removal | Procedure or surgery | Supragingival prophylaxis |
Primary outcome
Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels
Time frame: 2 months
IL-6 and CRP are markers of systemic inflammation and may improve at the end of gum treatment.
1 secondary outcome
Changes in periodontal (gum) clinical presentation and status
Time frame: 2 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2016.
- Background: PubMed 17032104Ioannidou E, Malekzadeh T, Dongari-Bagtzoglou A. Effect of periodontal treatment on serum C-reactive protein levels: a systematic review and meta-analysis. J Periodontol. 2006 Oct;77(10):1635-42. doi: 10.1902/jop.2006.050443.
- Background: PubMed 20412451Ioannidou E, Shaqman M, Burleson J, Dongari-Bagtzoglou A. Periodontitis case definition affects the association with renal function in kidney transplant recipients. Oral Dis. 2010 Oct;16(7):636-42. doi: 10.1111/j.1601-0825.2010.01665.x.
- Background: PubMed 21940520Ioannidou E, Swede H, Dongari-Bagtzoglou A. Periodontitis predicts elevated C-reactive protein levels in chronic kidney disease. J Dent Res. 2011 Dec;90(12):1411-5. doi: 10.1177/0022034511423394. Epub 2011 Sep 22.
- Background: PubMed 25984952Hong BY, Furtado Araujo MV, Strausbaugh LD, Terzi E, Ioannidou E, Diaz PI. Microbiome profiles in periodontitis in relation to host and disease characteristics. PLoS One. 2015 May 18;10(5):e0127077. doi: 10.1371/journal.pone.0127077. eCollection 2015.
- Results publication: PubMed 21422478Ioannidou E, Swede H. Disparities in periodontitis prevalence among chronic kidney disease patients. J Dent Res. 2011 Jun;90(6):730-4. doi: 10.1177/0022034511402209. Epub 2011 Mar 21.
- Results publication: PubMed 22775287Ioannidou E, Hall Y, Swede H, Himmelfarb J. Periodontitis associated with chronic kidney disease among Mexican Americans. J Public Health Dent. 2013 Spring;73(2):112-9. doi: 10.1111/j.1752-7325.2012.00350.x. Epub 2012 Jul 6.
- Results publication: PubMed 26055269Araujo MV, Hong BY, Fava PL, Khan S, Burleson JA, Fares G, Samson W, Strausbaugh LD, Diaz PI, Ioannidou E. End stage renal disease as a modifier of the periodontal microbiome. BMC Nephrol. 2015 Jun 9;16:80. doi: 10.1186/s12882-015-0081-x.
- Results publication: PubMed 24215204Ioannidou E, Swede H, Fares G, Himmelfarb J. Tooth loss strongly associates with malnutrition in chronic kidney disease. J Periodontol. 2014 Jul;85(7):899-907. doi: 10.1902/jop.2013.130347. Epub 2013 Nov 11.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Efthimia Ioannidou, DDS, MDS principal investigator
UConn Health
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Scaling root planing and Supragingival Prophylaxis in people with Periodontitis and Chronic Kidney Disease, run by UConn Health at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum Interleukin-6 (IL-6) and C-reactive protein (CRP) levels (time frame: 2 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01094639, which also lists 8 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2016.